Senior Clinical Research Associate/Clinical Research Associate II - Oncology

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

12 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

Parexel

Role Description The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials. - Oversight of Monitoring Responsibilities and Study Conduct - Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable laws, GCP, and sponsor standards. - Manage assigned operational aspects for implementation of clinical trial activities from site activation through to database lock. - Serve as the primary point of contact for assigned investigator sites. - Interface with the study team as needed, facilitating information flow between team members, vendors, and investigator sites. - Partner with SCP to perform investigator site development, coaching, and training of site personnel. - Attend investigator meetings when required and provide enrollment support. - Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities. - Monitor site level adverse events (AEs) and serious adverse events (SAEs). - Submit all required reports, documentation, updates, and tracking within required timeframes. - Identify and resolve investigator site issues within required timeframes. - Ensure adequate oversight of the investigational product at the investigator site. - Support database release as needed. - May undertake the responsibilities of an unblinded monitor where appropriate. - Maintain thorough understanding of the product, protocol, and therapy area. - Support the study clinician in ensuring patient safety and eligibility. - Drive Quality Event (QE) remediation when applicable. - Serve as a point of contact for audit conduct and drive Audit Observation corrective action/preventive action (CAPA) development. Qualifications - Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology). - Preferred therapeutic experience in Oncology. - Global clinical trial experience preferred. - Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations. - Fluent in English and in the native language(s) of the country they will work in. - Valid driver’s license and passport required. Requirements - Demonstrated knowledge of clinical research and development processes. - Understanding of global and local regulatory requirements. - Knowledge of key operational elements of clinical research. - Knowledge in disease and technical areas pertaining to clinical studies. - Ability to support sponsor regulatory interactions/inspections. - Understanding of region/country, culture, and medical practice affecting clinical trial delivery. - Proven ability to work in a matrix team environment. - Ability to evaluate, interpret, and present complex issues and data. - Effective verbal and written communication skills. Education - Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, or medical is required. Company Description

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$0 / year
Full TimeRemoteTeam 5,001-10,000H1B Sponsor

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Centene Corporation logo

Clinical Review Nurse-Concurrent Review

Centene Corporation

Centene Corporation is a Fortune 500, mission-driven healthcare leader committed to transforming the health of the communities we service, one person at a time.

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$27 - $49 / hour
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